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Faculty Disclosure Information As a Special Instrument Distributor (SID), Barbara Kurman has contractual relationships with most manufacturers whose products will be referred to in this presentation. In the past 12 months, Judith Gravel has not had a significant financial interest or other relationship with the manufacturer(s) of the product(s) or provider(s) of the service(s) that will be discussed in this presentation. This presentation will not include discussion of pharmaceuticals or devices that have not been approved by the FDA. There will be no discussion or unapproved or "off-label" uses of pharmaceuticals or devices.

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Agenda Background: review of newborn hearing screening programs – who are we missing? Technologies and current devices – what is commercially available? Should We Have Standards for NHS? Other NHS product considerations

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NIH 1993 Consensus Conference The preferred model for screening should begin with an evoked otoacoustic emissions test and should be followed by an auditory brainstem response test for all infants who fail the evoked otoacoustic emissions test.

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What hearing losses are we missing with newborn screening? The best screening tests are not 100% accurate Evidence suggests that at best, our screening tests are identifying about 80% - 90% of infants who have hearing loss in the newborn period (e.g., Norton et al., 2000; Davis et al., 1997; Lutman et al., 1997)

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What hearing losses are we missing with newborn screening? Missing deaf ears –Estimates of false-negative (false pass) rate: 1-2% of deaf ears will pass ABR screening (Roger Marsh, CHOP 2006 Repeated screening of a failed ear to achieve a pass will increase the likelihood of a pass response in a deaf ear

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Centers for Disease Control and Prevention (CDC) Request for Proposals - January 2000 Concerns have been raised about infants who fail OAE but pass ABR and are then dismissed from follow-up. These infants may have a mild loss that was missed by ABR

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Variability Based on the estimate of the RETSPL value, the results indicate that the stimulus levels in current equipment [automated ABR] are considerably above the stated stimulus level of 35 dB HL. Estimated: 38.5 to 44.9 dB HL Stevens 2004

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What the Products Have in Common Designed for ease of use - automation Parameters cannot be changed by screening personnel All provide only pass or refer outcome Probe tips or couplers (circumaural cushions) are disposable (single use) All identify some violation of proper test conditions: low stimulus level, too noisy.

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Calibration Manufacture Recommends: –Some recommend a yearly calibration: (e.g., on site by a NASED –certified audiometric technician or ship device back to factory) –Some recommend no annual calibration is needed NASED (National Association of Special Equipment Distributors) – examining calibration standards for OAE devices where no current national standards exist

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Problems Associated with the Lack of National Standards for NHS Programs Prevalence data may not be comparable across programs –Impacts our understanding of differences in prevalence among populations and geographic regions –Impacts public health, education, fiscal policy planning

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Comparing Within & Among NHS Data Sets NYS Demonstration Project – same protocol and pass/fail criteria English Screening program – same protocol and pass/fail criteria Ontario screening program – same protocol and pass/fail criteria U.S. screening program - variability of screening protocols & pass/fail criteria among hospitals & states and across the nation

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Problems Associated with the Lack of National Standards for NHS Programs Manufacturer algorithms designed to provide best performance (low fail rates) along with high sensitivity (most hearing losses identified) Pass-fail criteria differ among devices Few data from manufacturers on the statistical false-negative (false-pass) rate

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Commercially-Available Automated ABR Screening Products 5 of 6 manufacturers allow probe/ear canal transducer option –Verify level within tolerance parameters in order to run the test 2 of 6 manufacturers allow either probe/ear canal transducer or circumaural cushion option –Verify level within tolerance parameters in order to run the test

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Suggestions for How Screening Programs Can select an Appropriate Device Decide what you want to screen for (sensory, neural, mild HL, etc.) Consider the screening environment and screening personnel Require manufacturers specifications to reflect all stimulus parameters and pass/fail criteria Have a evidence-base for selection of screening parameters and pass/fail criteria